Phase 1 Study of IMC-1121B in Patients With Advanced Solid Tumors

Trial Information

Phase 1 Study of IMC-1121B in Patients With Advanced Solid Tumors

This single center, open-label, single-arm, Phase 1 study will enroll approximately 15 to 18
patients. The actual size will vary depending on the dose-limiting toxicities (DLTs)
observed and the resultant sizes of the cohorts. Patients will receive IMC-1121B,
administered intravenously, once every 2 or 3 weeks for 6 weeks (one cycle). After one
cycle of treatment, patients who have an objective response or stable disease may continue
to receive IMC-1121B at the same dose and schedule until disease progression or other
withdrawal criteria are met. A minimum of three patients will be enrolled in each cohort.
Dose escalation in successive cohorts will occur once all patients complete one cycle of
therapy.

Patients will be enrolled sequentially into each cohort.

A completed patient will be either a patient who completes the initial 6 week treatment
period (Cycle 1) or a patient who discontinues therapy for an IMC-1121B related toxicity
during Cycle 1. Patients who do not complete the first 6 weeks of treatment for reasons
other than an IMC-1121B -related toxicity will be replaced. Toxicity data for each cohort
will be reviewed prior to dose escalation. Upon completion of all required safety
evaluations during the initial 6 weeks, the next cohort of new patients will be treated at
the next higher dose level using a dose escalation scheme.

Inclusion Criteria:

- Solid tumor patient who was been histopathologically or cytologically documented.

- Advanced primary or recurrent solid tumors patient who has not responded to standard
therapy or no standard therapy is available.

- The patient has measurable or nonmeasurable lesions according to Response Evaluation
Criteria in Solid Tumors [RECIST].

- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS)
score of 0-1 at study entry.

- The patient's urinary protein is 0 on dipstick or 1+ but patient does not have edema
nor serum albumin < lower level of normal [LLN].

- The patient has adequate coagulation function, as defined by international normalized
ratio (INR) ≤ 1.5.

- The patient agrees to use adequate contraception during the study period and for 12
weeks after the last dose of study treatment.

Exclusion Criteria:

- The patient has had chemotherapy or therapeutic radiotherapy within 28 days (6 weeks
for nitrosoureas or mitomycin C) prior to entering the study or patient has ongoing
side effects ≥ Grade 2 due to agents administered more than 28 days earlier.

- The patient has obvious evidence of intratumor cavitation.

- The patient has undergone major surgery (eg, laparotomy, thoracotomy, removal of
organ[s]) within 28 days prior to study entry, or subcutaneous venous access device
placement within 7 days prior to study entry.

- The patient has a history of postoperative bleeding complications or wound
complications from a surgical procedure.

- The patient has elective or planned surgery to be conducted during the trial.

- The patient has documented and/or symptomatic brain or leptomeningeal metastases.
(Patients who are clinically stable [no symptoms during 4 weeks prior to the
enrollment] with an assessment that no further treatment [radiation, surgical
excision, and administration of steroids] is required, are permitted to enter the
study.)

- The patient has uncontrolled intercurrent illness including, but not limited to:

- Thrombotic or hemorrhagic disorders

- Hemoptysis (approximately one-half of a teaspoon)

- Ongoing or active infection requiring systemic antibiotic treatment

- Congestive heart failure (Class III or IV of the New York Heart Association
classification for heart disease)

- The patient has participated in clinical studies of non-approved experimental agents
or procedures within 4 weeks prior to study entry for small molecules, or 8 weeks
prior to study entry for non-approved monoclonal antibodies.

- The patient, if female, is pregnant (confirmed by urine or serum pregnancy test) or
lactating.

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